NCT04187105 BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
| NCT ID | NCT04187105 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Illinois at Chicago |
| Condition | Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2020-01-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 27 participants in total. It began in 2020-01-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).
Eligibility Criteria
Inclusion Criteria: 1. Patient age 18-75 years 2. Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor. * Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype. * Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches. 3. Eligible diagnoses are listed below. Patient must have one of the following: 1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia). 2. Poor-risk AML in first remission: * AML arising from MDS or a myeloproliferative disorder, or secondary AML * Poor risk molecular features including but not limited to presence of FLT3 internal tandem duplication mutation. * Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\> 3 abnormalities), inv(3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7 3. Poor risk ALL in first remission: * Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)/near triploidy (60-78 chromosomes) * Philadelphia-like ALL * Presentation WBC \>30 × 109 for B-ALL or \>100 109 for T-ALL * Age\>35 * Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry 4. Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features: * i. Poor-risk cytogenetics (including but not limited to 7/7q minus or complex cytogenetics) * ii. IPSS score of INT-2 or greater * iii. Treatment-related or Secondary MDS * iv. MDS diagnosed before age 21 years * v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy * vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions * vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations 5. Mixed lineage and biphenotypic leukemia 4. Adequate end-organ function as measured by: * a. Left ventricular ejection fraction ≥ 40% * b. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN * c. FEV1 and FVC \> 50% of predicted Exclusion Criteria: 1. Presence of significant co morbidity as shown by: * a. Left ventricular ejection fraction \< 40% * b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN * c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia * d. Karnofsky score \<70 * e. History of cirrhosis 2. Patients unable to sign informed consent 3. Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)
Contact & Investigator
Rondelli Damiano, MD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT04187105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04187105 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04187105 currently recruiting?
Yes, NCT04187105 is actively recruiting participants. Contact the research team at drond@uic.edu for enrollment information.
Where is the NCT04187105 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04187105 clinical trial?
NCT04187105 is sponsored by University of Illinois at Chicago. The principal investigator is Rondelli Damiano, MD at University of Illinois at Chicago. The trial plans to enroll 27 participants.
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